Effect of Folate Acid on Offspring Obesity | NCT02236208

Studies
Effect of Folate Acid on Offspring Obesity

NCT02236208

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Sep 11, 2014Estimated

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Pediatric Obesity

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xirong Guo, Vice-president of Nanjing Maternity and Child Health Care Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The level of folate acid of pregnancy women at first trimester		12 weeks of pregnancy

Secondary Outcomes

Measure	Description	Time Frame
The level of folate acid of pregnancy women at second trimester		20-24 weeks of pregnancy
The level of folate acid of pregnancy women at third trimester		28-40 weeks of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnancy women
children
Chinese

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women with the early, mid and late pregnancy; Chilren

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xirong Guo, Dr.	Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University		Nanjing	Jiangsu	210004	China

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided